EVIS EXERA III Bronchovideoscope Recalled Due to Veterinary Use Before Clinical Assignment
An EVIS EXERA III Bronchovideoscope was recalled after being used in a veterinary endoscopy procedure before assignment to healthcare facilities. The device presents a potential contamination risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with potential for contamination, as the device was used in a veterinary endoscopy procedure before being assigned to human healthcare use. No injuries or illnesses have been reported, making this a theoretical risk-of-harm case.
Plain-English summary
An EVIS EXERA III Bronchovideoscope, Model BF-XP190, manufactured by Aizu Olympus Co., Ltd., is being recalled. The device was used in a veterinary endoscopy procedure before being assigned to healthcare facilities as a loaner. This prior use raises contamination and safety concerns.
Healthcare facilities that received this device as a loaner should not use it for patient procedures. For information about the recalled device, contact Aizu Olympus Co., Ltd. or the FDA. The device was distributed in Florida, Illinois, North Carolina, Pennsylvania, and Texas.
The recalled product
- Product
- EVIS EXERA III Bronchovideoscope
- Manufacturer
- Aizu Olympus Co., Ltd.
- Category
- Medical Device — Endoscope
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI-DI: 04953170342134
- Serial No. 2911858
- Model No. BF-XP190.
Distribution
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